1. Field on the Invention
The present invention generally relates to ultrasonic surgical instruments and, more particularly, to harmonic scalpels for cutting bone and for cutting and/or coagulating tissue, for example.
2. Description of the Related Art
Ultrasonic surgical instruments can be used for the safe and effective treatment of many medical conditions. Generally, ultrasonic surgical instruments can be used to cut and/or coagulate organic tissue, for example, using energy in the form of ultrasonic vibrations, i.e., mechanical vibrations transmitted to a surgical end-effector at ultrasonic frequencies. These ultrasonic vibrations, when transmitted to organic tissue at suitable energy levels and using a suitable end-effector, may be used to cut and/or coagulate the tissue. Such instruments may be used for open procedures or minimally invasive procedures, such as endoscopic or laparoscopic procedures, for example, wherein the end-effector is passed through a trocar to reach a surgical site.
Although ultrasonic surgical instruments can perform their intended function remarkably well, the energy and vibrations created by these instruments is significant and, if not properly controlled, can unintentionally cause damage to tissue and/or bone surrounding the surgical site. As a result, several safety features have been developed to prevent, or at least reduce the possibility of, such damage from occurring. For example, some surgical instruments have been developed which include sheaths that extend around at least a portion of the end-effector. In use, these sheaths can prevent portions of the end-effector from unintentionally contacting tissue or bone surrounding the surgical site. However, these sheaths can block the surgeon's view of the surgical site, for example. As a result, the surgeon may not be able to readily ascertain the depth of their incisions and make corrective adjustments. What is needed is an improvement over the foregoing.
In at least one form of the invention, a surgical instrument can include a housing, a transducer engaged with the housing where the transducer is configured to produce vibrations, and an end-effector engaged with the transducer. In various embodiments, the end-effector can define an axis and a distal tip where the distal tip is movable along the axis by vibrations produced by the transducer. In at least one embodiment, the surgical instrument can further include an adjustable sheath extending from the housing where the sheath is movable relative to the distal tip of the end-effector. In these embodiments, the distance between the distal tip of the sheath and the distal tip of the end-effector can be set such that the sheath can act as a depth stop. More particularly, the sheath can be adjusted such that, when the distal tip of the sheath contacts the tissue or bone being incised, for example, the surgeon can readily determine that the appropriate depth of the incision has been reached. In other various embodiments, the end-effector can be moved with respect to the sheath in order to adjust the distance between the distal tip of the end-effector and the distal tip of the sheath.
In at least one form of the invention, a surgical instrument can include a sheath which is removably attached to the housing of the surgical instrument. In various embodiments, a kit can be provided which includes a plurality of sheaths where each sheath can have a different length and/or configuration. In at least one embodiment, the kit can include a first sheath and a second sheath where, when the first sheath is assembled to the housing, the distal tip of the end-effector and the distal tip of the first sheath define a first distance therebetween, and, when the second sheath is assembled to the housing, the distal tip of the end-effector and the distal tip of the second sheath define a second distance therebetween which is different than the first distance. In these embodiments, a surgeon can select a sheath from the kit such that the sheath, when its distal tip contacts the tissue or bone being incised, for example, allows the surgeon to readily determine that the desired depth of the incision has been reached.
In at least one form of the invention, a surgical instrument can include a housing, a transducer engaged with the housing where the transducer is configured to produce vibrations, and an end-effector engaged with the transducer. The end-effector can include a first treatment region, a second treatment region, and at least one indicium or demarcation on the end-effector configured to identify the first treatment region, for example. In at least one such embodiment, the first treatment region can include a cutting edge configured to cut tissue and the second treatment region can include an arcuate surface configured to cauterize or coagulate tissue where the at least one indicium or demarcation can allow a surgeon to readily identify such portions of the end-effector. Similarly, in at least one embodiment, the at least one indicium or demarcation can be configured to indicate which portions of the end-effector vibrate at a high intensity and which portions vibrate at a low intensity.
In at least one form of the invention, a surgical instrument can include a housing, a transducer engaged with the housing where the transducer is configured to produce vibrations, and an end-effector engaged with the transducer. The end-effector can further include a clamp having a jaw member and a pivot where the jaw member is rotatable with respect to the end-effector between an open position and a closed position about the pivot. In addition, the clamp can be translatable between a first position and a second position with respect to the distal tip of the end-effector. In these embodiments, the jaw member can be used, if desired, to hold tissue against the end-effector as it is being incised, for example, or, alternatively, the clamp can be translated away from the distal tip of the end-effector such that the end-effector can be used without the clamp. Such features allow the surgeon to use one instrument to perform various tasks where more than one instrument was previously required to perform the same tasks.
The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate preferred embodiments of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
As indicated above, ultrasonic surgical instruments can be used to cut, cauterize, and/or coagulate organic tissue, for example, using energy in the form of ultrasonic vibrations, i.e., mechanical vibrations transmitted to a surgical end-effector at ultrasonic frequencies. Examples of ultrasonic surgical instruments are disclosed in U.S. Pat. Nos. 5,322,055, 5,954,736, 6,278,218, 6,283,981, 6,309,400, and 6,325,811, the disclosures of which are incorporated by reference herein in their entirety. In various embodiments, an ultrasonic signal generator can be provided which produces a desired electrical signal and can be connected to a handpiece of the surgical instrument by a cable. A suitable generator is available as model number GEN04, from Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. In one embodiment, referring to
Referring to
In use, the longitudinal waves created by transducer 18 can produce longitudinal vibratory movement of waveguide 20 and end-effector 22 mounted thereto. In at least one embodiment, the drive current can include an alternating current defined by a substantially sinusoidal frequency which, owing to the excitation of elements 16 described above, causes waveguide 20 and end-effector 22 to vibrate longitudinally in a substantially sinusoidal manner. In various embodiments, transducer 18 can be configured such that waveguide 20 and end-effector 22 are vibrated at a preselected resonant frequency. In at least one such embodiment, piezoceramic elements 16 can be driven at ultrasonic frequencies including frequencies between approximately 50,000 and approximately 60,000 cycles per second, for example. In other embodiments, elements 16 can be driven at frequency greater than or equal to approximately 20,000 cycles per second. In addition to the above, the magnitude of the drive current voltage can dictate the magnitude of the displacement of end-effector 22.
When piezoceramic elements 16 are energized, a vibratory motion standing wave is generated through transducer 18, waveguide 20 and end-effector 22. The amplitude of the vibratory motion at any point along these components may depend upon the location at which the vibratory motion is measured. For example, at some locations along wave guide 20 and end-effector 22, the vibratory motion may be at a higher intensity or amplitude and, at other locations, at a lower intensity or amplitude. At some locations, the vibratory motion is zero, or substantially zero. A minimum or zero point in the vibratory motion standing wave is generally referred to as a node whereas a maximum or peak in the standing wave is generally referred to as an anti-node. The distance between an anti-node and an adjacent node is approximately one-quarter wavelength of the standing wave frequency, i.e., λ/4. These nodal locations also correspond to the relative maximum stress locations in the system whereas the anti-nodes correspond to relative minimum stress locations.
In order to transmit the standing wave from transducer 18 to waveguide 20, waveguide 20 must be acoustically coupled to transducer 18, i.e., they must be attached in such a way that mechanical vibrations produced by transducer 18 are transmitted into wave guide 20. Similarly, in order to transmit these vibrations to the distal tip of end-effector 22, waveguide 20 and end-effector 22 must also be acoustically coupled if manufactured as separate components. In preferred embodiments, such couplings are configured to substantially coincide with the anti-nodes of the standing wave such that little, if any, vibratory stress is present at the couplings. In these embodiments, as a result, the possibility of transducer 18, waveguide 20 and end-effector 22 becoming decoupled is reduced.
In various embodiments, transducer 18, waveguide 20 and end-effector 22 can comprise an assembly which can be driven at, or close to, its resonant, or natural, frequency and amplify the motion initiated by transducer 18. In the illustrated embodiment, end-effector 22 comprises a blade which is integral with waveguide 20 and can be constructed from a material suitable for transmission of ultrasonic energy such as, for example, Ti6Al4V (an alloy of titanium including aluminum and vanadium), aluminum, stainless steel, or other known materials. Alternately, blade 22 may be manufactured as a separate component and can be comprised of a different material than waveguide 20, for example. In these embodiments, blade 22 and waveguide 20 can be coupled by a stud, a threaded connection or by any suitable process including welding, gluing, or other known methods, for example. In various embodiments, at least portions of the waveguide, blade and transducer can be comprised of a continuous material
In order to operate the ultrasonic surgical system in an efficient manner, the frequency of the signal supplied to transducer 18 can be swept over a range of frequencies to locate the resonance frequency. In at least one embodiment, a switch, such as switch 24, on hand piece 12 can be manipulated to activate the signal sweep. Once the resonance frequency is found, generator 10 can lock onto the resonance frequency, monitor the transducer current to voltage phase angle, and adjust the drive current such that it drives the waveform and blade assembly at, or close to, the resonance frequency. In at least one embodiment, once the generator has locked onto the resonant frequency, an audio indicator, for example, can be communicated to the user to indicate the same. Once the resonant frequency of the system has been determined, the drive current can be immediately supplied to hand piece 12 and/or the drive current may be controlled by the operation of switch 24 located thereon, for example. In other embodiments, the drive current may be controlled by foot switch 26 which is connected to generator 10 by cable 28.
Referring to
In various embodiments, as discussed in further detail below, the position of sheath 56 can be adjusted to change the distance between distal tip 55 of end-effector 54 and distal tip 57 of sheath 56. In at least one such embodiment, referring to
Referring primarily to
In order to move rack 62 relative to housing 52, in the present embodiment, actuator 58 can be engaged with ratchet mechanism 60 such that, when actuator 58 is moved toward handle 60, ratchet mechanism 60 slides rack 62 proximally with respect to distal tip 55 of end-effector 54. Referring primarily to
Referring to
Referring to
To move sheath 56 distally toward distal end 55 of end-effector 54, ratchet mechanism 60 can include a release mechanism which disengages pawl 63 from ratchet wheel 61. More particularly, referring to
As described above, a surgeon can use distal end 57 of sheath 56 as a depth stop. In use, the surgeon can select the distance between distal end 57 of sheath 56 and distal end 55 of end-effector 54 such that distance between distal ends 55 and 57 equals the depth to which the surgeon desires to incise the tissue or bone. To assist the surgeon in determining the distance between distal end 55 and distal end 57, surgical instrument 50 can include depth indicator 88. More particularly, referring to
In the present embodiment, transducer 90 can be mounted to housing 52 as known in the art. In alternative embodiments, referring to surgical instrument 150 illustrated in
In various embodiments of the present invention, a surgical instrument can include a sheath which is rotatably extendable and/or retractable with respect to the housing of the surgical instrument. Referring to
In various embodiments, the surgical instrument can include, referring to
In various embodiments of the present invention, a surgical instrument can include a sheath comprising two or more telescoping portions. Referring to
In various embodiments of the present invention, a surgical instrument can include at least two relatively collet-like slidable portions and a collar, for example, for fixedly securing the slidable portions together. More particularly, referring to
In various embodiments of the present invention, a surgical instrument can include a detachable sheath. More particularly, in at least one embodiment, referring to
In various embodiments of the present invention, a surgical instrument can include a detachable end-effector. More particularly, in at least one embodiment, referring to
In various embodiments of the present invention, a surgical instrument can include an end-effector having at least one indicium or demarcation which is configured to identify a treatment region of the end-effector. More particularly, the end-effector can, referring to
In various embodiments, the indicium may include a coated surface. Such coating can be applied by conventional methods including annodization, for example. In embodiments where both first treatment region 830 and second treatment region 831 are coated, the coatings can have different colors, textures, thicknesses and/or be comprised of different materials, for example. In various embodiments, one of the treatment regions may be dyed such that it has a different color than the other treatment region. In at least one embodiment, a treatment region having a cutting edge or surface may be coated or dyed with a material having a bright color, such as red, orange or yellow, for example. Similarly, a treatment region having a surface for cauterizing or coagulating tissue may be coated or dyed with a material having a dark color such as green, blue or indigo, for example. In various embodiments, at least one of the surfaces of first treatment region 830 and second treatment region 831 can have a modified surface finish. In at least one such embodiment, at least a portion of the surface can be etched or bead-blasted, for example, to create a textured surface finish. In embodiments where both treatment regions are etched, for example, the degree of etching may be different to allow the surgeon to more readily distinguish between the treatment regions. In at least one embodiment, the indicium can include numbers, letters or symbols printed thereon or engraved therein.
In various embodiments, the demarcation may include at least one groove in the surface of the end-effector which can provide delineation between the treatment regions. In at least one embodiment, the entire surface of a treatment region can include a plurality of grooves that may, in various embodiments, be arranged in an organized pattern of hatching, for example. In at least one embodiment, the first and second treatment regions can both include grooves or other demarcations where the density of the grooves or demarcations can be different in the first treatment region than in the second treatment region. In various embodiments, the density of the demarcations can include gradual changes which can be configured indicate changes in the intensity or amplitude of vibrations, for example, along the length of the end-effector. As a result of such changes in the demarcations, a surgeon can readily discern portions of the end-effector vibrating at maximum and minimum intensities and intensities therebetween. In at least one such embodiment, the density of pigmentation, for example, on an end-effector can be greatest at a node, or anti-node, for example, and gradually decrease at increasing distances from the node, or anti-node. In various embodiments, the rate of change in the density of pigmentation, for example, can be linear or, in other embodiments, it can be geometric. Embodiments having a geometric rate of change in the demarcations can, in at least some embodiments, more accurately represent the change in the intensity of the vibrations caused by the standing sinusoidal wave. Although the embodiments outlined above have been described as having first and second treatment regions, the present invention is not so limited. On the contrary, the end-effector may include more than two treatment regions each having at least one indicium and/or demarcation or no indicium or demarcation at all.
Further to the above, in various embodiments, at least one indicium or demarcation can be used to identify portions of the end-effector which have either high or low vibrational intensities or amplitudes, for example. More particularly, as described above, the transducer of the surgical instrument can generate a standing wave in the end-effector which creates nodes and anti-nodes along the length of the end-effector. These nodes and anti-nodes represent high and low regions of vibrational intensity, respectively, of the end-effector which can be utilized by a surgeon. For example, the high intensity regions of the end-effector can be used to incise or cauterize tissue, for example, whereas the low intensity regions of the end-effector can be used to safely contact the tissue surrounding the surgical site. As these nodes and anti-nodes are typically indiscernible to the surgeon, an indicium or demarcation may be provided on the end-effector to allow the surgeon to readily discern these regions of the end-effector.
In various embodiments of the present invention, a surgical instrument can include a retractable clamp configured to hold at least a portion of a bone or tissue, for example, against the end-effector of the surgical instrument. In at least one embodiment, the clamp, when it is extended, can be configured to act as a rongeur or kerrison, for example, configured to hold at least a portion of a bone against the end-effector to remove small portions of the bone. The clamp, when it is at least partially retracted, can allow the end-effector to be used as an ultrasonic cobb or curette to dissect tissue or elevate the tissue from a bone, for example. In addition, the end effector can, when the clamp is at least partially retracted, be used as an osteotome and can be used to chisel or resect bone without the use of ultrasonic energy.
In various embodiments, referring generally to
In various embodiments, referring to
In various embodiments, referring to
In various embodiments, referring to
In various embodiments, referring to
In use, a surgeon may be provided with a kit comprising surgical instrument 1100 and a plurality of jaw members. The surgeon may select a desired jaw member from the plurality of jaw members and attach the selected jaw member to surgical instrument 1100 as described above. Thereafter, the surgeon may use the same surgical instrument 1100 with a different jaw member, such as jaw member 1236 illustrated in
As described above, a surgical instrument having a retractable clamp can be used for at least three purposes. The first purpose can be to use the clamp to hold tissue or bone against an end-effector where ultrasonic energy applied to the end-effector can be used to cut the tissue or bone therebetween. The second purpose can be to at least partially retract the clamp so that the end-effector can be used to incise or elevate tissue from bone, for example, via ultrasonic energy applied to the end-effector. The third purpose can be to, again, at least partially retract the clamp so that the end-effector can be used without ultrasonic energy applied thereto. In these circumstances, the end-effector can be used to chisel bone, for example, by striking the end of the surgical instrument with a mallet. In various embodiments, an end-effector configured to incise tissue with ultrasonic energy may be unsuitable for striking bone and, as a result, such an end-effector can be replaced with an end-effector more resembling the end of a chisel, for example.
While several embodiments of the invention have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the invention. For example, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the disclosed invention as defined by the appended claims.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device may be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular elements, and subsequent reassembly. In particular, the device may be disassembled, and any number of particular elements or components of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device may utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
The present application is a continuation application claiming priority under U.S.C. §120 from U.S. patent application Ser. No. 13/414,819, entitled SURGICAL INSTRUMENTS, filed on Mar. 8, 2012, now U.S. Pat. No. 8,900,259, which is a divisional application claiming priority under U.S.C. §121 from U.S. patent application Ser. No. 11/726,620, entitled SURGICAL INSTRUMENTS, filed on Mar. 22, 2007, now U.S. Pat. No. 8,142,461, the entire disclosures of which are hereby incorporated by reference. The present application is also related to the following commonly-owned U.S. Patent Applications filed on Mar. 22, 2007, and which are hereby incorporated by reference in their entirety: (1) U.S. patent application Ser. No. 11/726,625, entitled SURGICAL INSTRUMENTS, now U.S. Pat. No. 8,911,460; (2) U.S. patent application Ser. No. 11/726,760, entitled ULTRASONIC SURGICAL INSTRUMENTS, now U.S. Pat. No. 8,226,675; and (3) U.S. patent application Ser. No. 11/726,621, entitled ULTRASONIC SURGICAL INSTRUMENTS AND CARTILAGE BONE SHAPING BLADES THEREFOR, now U.S. Patent Application Publication No. 2008/0234709.
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Number | Date | Country | |
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20150045819 A1 | Feb 2015 | US |
Number | Date | Country | |
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Parent | 11726620 | Mar 2007 | US |
Child | 13414819 | US |
Number | Date | Country | |
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Parent | 13414819 | Mar 2012 | US |
Child | 14525459 | US |